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Trial registered on ANZCTR
Registration number
ACTRN12614001102662
Ethics application status
Approved
Date submitted
29/09/2014
Date registered
16/10/2014
Date last updated
9/02/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Reducing pre-drinking alcohol consumption and alcohol-related harm in university undergraduates: A randomized controlled trial of a psychological theory-based intervention
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Scientific title
A randomized controlled trial of a psychological theory-based intervention to reduce pre-drinking alcohol consumption and alcohol-related harm in university undergraduates
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Secondary ID [1]
285195
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption
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Alcohol-related harm
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Condition category
Condition code
Mental Health
293098
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0
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Addiction
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Public Health
293508
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomly allocated to one of four conditions: (1) autonomy support, (2) implementation intention, (3) combined autonomy support and implementation intention, and (4) a control. Intervention components have been developed and written by the researchers, and will be automatically presented to participants as they progress through an online survey tool (Qualtrics). The one-time intervention will be of approximately 30-minute duration, depending on participants' progression through questions and content.
All conditions will receive National Health and Medical Research Council guidelines on alcohol consumption to reduce the risk of harm.
Participants receiving the autonomy support component will be asked to generate their own reasons for pursuing reduced pre-drinking alcohol consumption that are consistent with their needs and perceived as beneficial.
Participants receiving the implementation intention component will formulate their own if-then plans to be enacted in certain pre-drinking contexts, to help attain the goal of reduced pre-drinking alcohol consumption.
Participants in the combined condition will receive the autonomy support component to facilitate autonomous motivation to reduce pre-drinking alcohol consumption, then the implementation intention component to help translate this motivation into action by generating if-then statements to be enacted in response to certain contextual cues.
Participants' responses to the intervention components (i.e., prompts) will be content analyzed for monitoring adherence to the intervention. Participants will be emailed their respective intervention components following the completion of the intervention, and will complete a brief follow-up, four weeks later, to ascertain the effects of the intervention on reducing pre-drinking alcohol consumption and alcohol-related harm. Participants will be send a weekly text message (SMS) reflecting the content they received in the intervention (e.g., participants in the implementation intention condition will receive an SMS each week reminding them of their if-then plans to reduce pre-drinking alchol consumption).
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Intervention code [1]
290063
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Behaviour
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Intervention code [2]
290064
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Lifestyle
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Intervention code [3]
290395
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Prevention
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Comparator / control treatment
Participants will receive two of the National Health and Medical Research Council's guidelines to reduce alcohol-related harm. Specifically, these guidelines state:
(1) For healthy men and women, drinking no more than two standard drinks on any day reduces the lifetime risk of harm from alcohol-related disease or injury
(2) For healthy men and women, drinking no more than four standard drinks on a single occasion reduces the risk of alcohol-related injury arising from that occasion.
These statements will be delivered to all participants within the online survey tool (Qualtrics) and emailed upon completion of the intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pre-drinking alcohol consumption (in standard drink equivalents) over the past four weeks from baseline, as measured by self-report with aid of a pictorial guide from the National Health and Medical Research Council's standard drink equivalent guide to assist in accurate self-reporting.
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Assessment method [1]
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Timepoint [1]
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Baseline and follow-up (four weeks after receiving the intervention).
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Secondary outcome [1]
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Alcohol-related harm experienced over the previous four weeks, as measured by a psychometric scale of alcohol-related harm; the Brief Young Adult Alcohol Consequences Scale (B-YAACQ). The B-YAACQ allows participants to respond with a 'yes' or 'no' answer to a series of statements reflecting experienced alcohol-related harm (e.g., "I have taken foolish risks when I have been drinking"). 'Yes' answers are summed to create an index of alcohol-related harm. The measure has been modified to reflect experience of alcohol-related harm in the previous four weeks, as opposed to the previous 12 months, to better ascertain the potential changes in alcohol-related harm as a result of the intervention.
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Assessment method [1]
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Timepoint [1]
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Baseline and follow-up (four weeks' after receiving the intervention).
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Eligibility
Key inclusion criteria
Current university undergraduate 'pre-drinkers' (i.e., those who report pre-drinking within the previous 12 months). Pre-drinking will be defined consistent with previous uses throughout empirical studies, as follows:
"The practice of consuming alcohol prior to attending a subsequent social event, where alcohol consumption often continues."
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Non-drinkers
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants access the intervention online. An online survey tool block randomises participants to one of the four conditions.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation concealment, involved central randomization by computer (Qualtrics random allocation tool).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A MANCOVA will be used to ascertain the effect of the intervention components (i.e., autonomy support (present/absent); implementation intention (present/absent) on outcomes (self-reported pre-drinking alcohol consumption and alcohol-related harm [B-YAACQ]). Power analysis indicates a conservative sample size estimate of 341 participants to detect a significant small-to-medium effect as found in a meta-analysis of online health behavioral interventions targeting alcohol consumption (i.e., d+ = .14) and a previous implementation intention intervention (eta-squared .02 to .07) of the intervention on outcome variables.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
15/03/2015
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Actual
27/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
341
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Individual
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Name
Professor Martin Hagger
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Address
Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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A/Prof Barbara Mullan
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Address [1]
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Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
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Country [1]
288503
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Mr Kim Caudwell
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Address [1]
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Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee
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Ethics committee address [1]
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Human Research Ethics Committee Office of Research and Development Curtin University GPO Box U 1987 Perth, Western Australia 6845
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/08/2014
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Approval date [1]
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24/09/2014
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Ethics approval number [1]
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HR185/2014
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Summary
Brief summary
The present study investigates a psychological theory-based intervention to reduce alcohol pre-drinking - the practice of consuming alcohol at a home or private residence, prior to attending a subsequent event (where alcohol consumption often continues). The intervention comprises a motivational component that facilitates autonomous motivation to reduce pre-drinking alcohol consumption, and a volitional component that enables participants to generate their own 'if-then' plans to enact in response to contextual cues surrounding pre-drinking. The intervention comprises four conditions: an autonomy support only, an implementation intention only, a combined, and control condition. The control condition will receive information from the National Health and Medical Research Council guidelines with respect to consuming alcohol in moderation to reduce the risk of alcohol-related harm. It is hypothesized that the controlled condition targeting both motivational and volitional aspects will be most effective in reducing pre-drinking alcohol consumption and alcohol-related harm.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Martin Hagger
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Address
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Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
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Country
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Australia
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Phone
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+61 8 9266 9266
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Fax
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Email
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martin.hagger@curtin.edu.au
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Contact person for public queries
Name
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Kim M Caudwell
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Address
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Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
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Country
50803
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Australia
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Phone
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+61 402 740 310
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Fax
50803
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Email
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kim.caudwell@postgrad.curtin.edu.au
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Contact person for scientific queries
Name
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Barbara Mullan
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Address
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Health Psychology and Behavioral Medicine Research Group
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
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Country
50804
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Australia
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Phone
50804
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+61 8 9266 9266
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Fax
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Email
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barbara.mullan@curtin.edu.au
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Combining motivational and volitional approaches to reducing excessive alcohol consumption in pre-drinkers: a theory-based intervention protocol.
2016
https://dx.doi.org/10.1186/s12889-015-2648-7
N.B. These documents automatically identified may not have been verified by the study sponsor.
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